Guidelines and Guidance
1
CONSORT 2010 Statement: Updated Guidelines for
Reporting Parallel Group Randomised Trials
Kenneth F. Schulz1*, Douglas G. Altman2, David Moher3, for the CONSORT Group"
1 Family Health International, Research Triangle Park, North Carolina, United States of America, 2 Centre for Statistics in Medicine, University of Oxford, Wolfson College,
Oxford, United Kingdom, 3 Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community
Medicine, University of Ottawa, Ottawa, Canada
Introduction
indirect goal of our work. Moreover, CONSORT can help
researchers in designing their trial.
Randomised controlled trials, when appropriately designed,
conducted, and reported, represent the gold standard in evaluating
healthcare interventions. However, randomised trials can yield
biased results if they lack methodological rigour [1]. To assess a
trial accurately, readers of a published report need complete, clear,
and transparent information on its methodology and findings.
Unfortunately, attempted assessments frequently fail because
authors of many trial reports neglect to provide lucid and
complete descriptions of that critical information [2,3,4].
That lack of adequate reporting fuelled the development of the
original CONSORT (Consolidated Standards of Reporting Trials)
statement in 1996 [5] and its revision five years later [6,7,8]. While
those statements improved the reporting quality for some
randomised controlled trials [9,10], many trial reports still remain
inadequate [2]. Furthermore, new methodological evidence and
additional experience has accumulated since the last revision in
2001. Consequently, we organised a CONSORT Group meeting
to update the 2001 statement [6,7,8]. We introduce here the result
of that process, CONSORT 2010.
Background to CONSORT
Efforts to improve the reporting of randomised controlled trials
accelerated in the mid-1990s, spurred partly by methodological
research. Researchers had shown for many years that authors
reported such trials poorly, and empirical evidence began to
accumulate that some poorly conducted or poorly reported aspects
of trials were associated with bias [14] Two initiatives aimed at
developing reporting guidelines culminated in one of us (DM) and
Drummond Rennie organising the first CONSORT statement in
Citation: Schulz KF, Altman DG, Moher D, CONSORT Group (2010) CONSORT
2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised
Trials. PLoS Med 7(3): e1000251. doi:10.1371/journal.pmed.1000251
Published March 24, 2010
Copyright: ! 2010 Schulz et al. This is an open-access article distributed under
the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the
original author and source are credited.
Intent of CONSORT 2010
Funding: The authors received financial support from United Kingdom National
Institute for Health Research and the Medical Research Council; Canadian
Institutes of Health Research; Presidents Fund, Canadian Institutes of Health
Research; Johnson & Johnson; BMJ; and the American Society for Clinical
Oncology. DGA is supported by Cancer Research UK, DM by a University of
Ottawa Research Chair, and KFS by Family Health International. None of the
sponsors had any involvement in the planning, execution, or writing of the
CONSORT documents. Additionally, no funder played a role in drafting the
manuscript. DM is on the Editorial Board of PLoS Medicine.
The CONSORT 2010 Statement is this paper including the 25
item checklist in the table (Table 1) and the flow diagram
(Figure 1). It provides guidance for reporting all randomised
controlled trials, but focuses on the most common design type—
individually randomised, two group, parallel trials. Other trial
designs, such as cluster randomised trials and non-inferiority trials,
require varying amounts of additional information. CONSORT
extensions for these designs, [11,12] and other CONSORT
products, can be found through the CONSORT website (http://
www.consort-statement.org). Along with the CONSORT statement, we have updated the explanation and elaboration article,
[13] which explains the inclusion of each checklist item, provides
methodological background, and gives published examples of
transparent reporting.
Diligent adherence by authors to the checklist items facilitates
clarity, completeness, and transparency of reporting. Explicit
descriptions, not ambiguity or omission, best serve the interests of
all readers. Note that the CONSORT 2010 Statement does not
include recommendations for designing, conducting, and analysing trials. It solely addresses the reporting of what was done and
what was found.
Nevertheless, CONSORT does indirectly affect design and
conduct. Transparent reporting reveals deficiencies in research if
they exist. Thus, investigators who conduct inadequate trials, but
who must transparently report, should not be able to pass through
the publication process without revelation of their trial’s
inadequacies. That emerging reality should provide impetus to
improved trial design and conduct in the future, a secondary
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Competing Interests: Uniform disclosure of potential conflicts of interest: all
authors have completed the ICMJE unified competing interest form at http://
www.icmje.org/coi_disclosure.pdf (available from the corresponding author) and
declare (1) DM received grants for this work from Johnson & Johnson, BMJ, and
American Society for Clinical Oncology; KFS and DGA received support for travel
to meetings for this work from Johnson & Johnson, BMJ, and American Society for
Clinical Oncology; (2) KFS and DA had travel expenses reimbursed by the
EQUATOR Network; KFS has received honoraria for delivering educational
presentations for the American Board of Obstetrics and Gynecology Foundation
for Excellence in Women’s Health Care, Ortho-McNeil Janssen Scientific Affairs,
and the American College of Obstetrics and Gynecology; and has done
consultancy for Wyeth. All authors also declare (3) no spouses, partners, or
children with relationships with commercial entities that might have an interest in
the submitted work; (4) no non-financial interests that may be relevant to the
submitted work.
* E-mail: [email protected]
" Membership of the CONSORT Group is provided in the Acknowledgments.
KFS is distinguished scientist and vice president of Family Health International,
DGA is professor at University of Oxford, and DM is senior scientist at Ottawa
Hospital Research Institute.
Provenance: Not commissioned; externally peer reviewed. In order to
encourage dissemination of the CONSORT 2010 Statement, this article is freely
accessible on bmj.com and will also be published in the Lancet, Obstetrics and
Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of
Clinical Epidemiology, BMC Medicine, and Trials. The authors jointly hold the
copyright of this article. For details on further use, see the CONSORT website
(www.consort-statement.org).
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March 2010 | Volume 7 | Issue 3 | e1000251
Table 1. CONSORT 2010 checklist of information to include when reporting a randomised trial (for a downloadable version of this
checklist see Text S1 or the CONSORT website).*
Section/Topic
Item
No
Checklist item
Reported on
page No
1a
Identification as a randomised trial in the title
1b
Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT
for abstracts [21,31])
Title and abstract
Introduction
Background and objectives
2a
Scientific background and explanation of rationale
2b
Specific objectives or hypotheses
Methods
Trial design
Participants
3a
Description of trial design (such as parallel, factorial) including allocation ratio
3b
Important changes to methods after trial commencement (such as eligibility criteria), with reasons
4a
Eligibility criteria for participants
4b
Settings and locations where the data were collected
Interventions
5
The interventions for each group with sufficient details to allow replication, including how and when they
were actually administered
Outcomes
6a
Completely defined pre-specified primary and secondary outcome measures, including how and when
they were assessed
6b
Any changes to trial outcomes after the trial commenced, with reasons
Sample size
7a
How sample size was determined
7b
When applicable, explanation of any interim analyses and stopping guidelines
Randomisation:
Sequence generation
8a
Method used to generate the random allocation sequence
8b
Type of randomisation; details of any restriction (such as blocking and block size)
Allocation concealment
mechanism
9
Mechanism used to implement the random allocation sequence (such as sequentially numbered
containers), describing any steps taken to conceal the sequence until interventions were assigned
Implementation
10
Who generated the random allocation sequence, who enrolled participants, and who assigned participants
to interventions
11a
If done, who was blinded after assignment to interventions (for example, participants, care providers, those
assessing outcomes) and how
11b
If relevant, description of the similarity of interventions
Blinding
Statistical methods
12a
Statistical methods used to compare groups for primary and secondary outcomes
12b
Methods for additional analyses, such as subgroup analyses and adjusted analyses
13a
For each group, the numbers of participants who were randomly assigned, received intended treatment,
and were analysed for the primary outcome
13b
For each group, losses and exclusions after randomisation, together with reasons
Results
Participant flow (a diagram is
strongly recommended)
Recruitment
14a
Dates defining the periods of recruitment and follow-up
14b
Why the trial ended or was stopped
Baseline data
15
A table showing baseline demographic and clinical characteristics for each group
Numbers analysed
16
For each group, number of participants (denominator) included in each analysis and whether the analysis
was by original assigned groups
Outcomes and estimation
17a
For each primary and secondary outcome, results for each group, and the estimated effect size and its
precision (such as 95% confidence interval)
17b
For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Ancillary analyses
18
Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing
pre-specified from exploratory
Harms
19
All important harms or unintended effects in each group (for specific guidance see CONSORT for harms [28])
Limitations
20
Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses
Generalisability
21
Generalisability (external validity, applicability) of the trial findings
Interpretation
22
Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
23
Registration number and name of trial registry
Discussion
Other information
Registration
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March 2010 | Volume 7 | Issue 3 | e1000251
Table 1. Cont.
Section/Topic
Item
No
Reported on
page No
Checklist item
Protocol
24
Where the full trial protocol can be accessed, if available
Funding
25
Sources of funding and other support (such as supply of drugs), role of funders
*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration [13] for important clarifications on all the items. If
relevant, we also recommend reading CONSORT extensions for cluster randomised trials [11], non-inferiority and equivalence trials [12], non-pharmacological
treatments [32], herbal interventions [33], and pragmatic trials [34]. Additional extensions are forthcoming: for those and for up to date references relevant to this
checklist, see http://www.consort-statement.org.
doi:10.1371/journal.pmed.1000251.t001
Indeed, CONSORT Group members continually monitor the
literature. Information gleaned from these efforts provides an
evidence base on which to update the CONSORT statement. We
add, drop, or modify items based on that evidence and the
recommendations of the CONSORT Group, an international and
eclectic group of clinical trialists, statisticians, epidemiologists, and
biomedical editors. The CONSORT Executive (KFS, DGA, DM)
1996. [5] Further methodological research on similar topics
reinforced earlier findings [15] and fed into the revision of 2001.
[6,7,8] Subsequently, the expanding body of methodological
research informed the refinement of CONSORT 2010. More
than 700 studies comprise the CONSORT database (located on
the CONSORT website), which provides the empirical evidence
to underpin the CONSORT initiative.
Figure 1. Flow diagram of the progress through the phases of a parallel randomised trial of two groups (that is, enrolment,
intervention allocation, follow-up, and data analysis). (For a downloadable version of this diagram see Figure S1 or the CONSORT website.)
doi:10.1371/journal.pmed.1000251.g001
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March 2010 | Volume 7 | Issue 3 | e1000251
strives for a balance of established and emerging researchers. The
membership of the group is dynamic. As our work expands in
response to emerging projects and needed expertise, we invite
new members to contribute. As such, CONSORT continually
assimilates new ideas and perspectives. That process informs the
continually evolving CONSORT statement.
Over time, CONSORT has garnered much support. More
than 400 journals, published around the world and in many
languages, have explicitly supported the CONSORT statement.
Many other healthcare journals support it without our knowledge. Moreover, thousands more have implicitly supported it
with the endorsement of the CONSORT statement by the
International Committee of Medical Journal Editors (http://
www.icmje.org). Other prominent editorial groups, the Council
of Science Editors and the World Association of Medical Editors,
officially support CONSORT. That support seems warranted:
when used by authors and journals, CONSORT seems to
improve reporting. [9]
numbers, we kept the existing items under their previous item
numbers except for some renumbering of items 2 to 5. We added
additional items either as a sub-item under an existing item, an
entirely new item number at the end of the checklist, or (with item
3) an interjected item into a renumbered segment. We have
summarised the noteworthy general changes in Box 1 and specific
changes in Box 2. The CONSORT website contains a side by side
comparison of the 2001 and 2010 versions.
Implications and Limitations
We developed CONSORT 2010 to assist authors in writing
reports of randomised controlled trials, editors and peer reviewers
in reviewing manuscripts for publication, and readers in critically
appraising published articles. The CONSORT 2010 Explanation
and Elaboration provides elucidation and context to the checklist
items. We strongly recommend using the explanation and
elaboration in conjunction with the checklist to foster complete,
clear, and transparent reporting and aid appraisal of published
trial reports.
CONSORT 2010 focuses predominantly on the two group,
parallel randomised controlled trial, which accounts for over half
of trials in the literature. [2] Most of the items from the
CONSORT 2010 Statement, however, pertain to all types of
randomised trials. Nevertheless, some types of trials or trial
situations dictate the need for additional information in the trial
report. When in doubt, authors, editors, and readers should
consult the CONSORT website for any CONSORT extensions,
expansions (amplifications), implementations, or other guidance
that may be relevant.
The evidence based approach we have used for CONSORT
also served as a model for development of other reporting
guidelines, such as for reporting systematic reviews and metaanalyses of studies evaluating interventions, [16] diagnostic studies,
[17] and observational studies. [18] The explicit goal of all these
initiatives is to improve reporting. The Enhancing the Quality and
Transparency of Health Research (EQUATOR) Network will
facilitate development of reporting guidelines and help disseminate
the guidelines: http://www.equator-network.org provides information on all reporting guidelines in health research.
Development of CONSORT 2010
Thirty one members of the CONSORT 2010 Group met in
Montebello, Canada, in January 2007 to update the 2001
CONSORT statement. In addition to the accumulating evidence
relating to existing checklist items, several new issues had come to
prominence since 2001. Some participants were given primary
responsibility for aggregating and synthesising the relevant
evidence on a particular checklist item of interest. Based on that
evidence, the group deliberated the value of each item. As in prior
CONSORT versions, we kept only those items deemed absolutely
fundamental to reporting a randomised controlled trial. Moreover,
an item may be fundamental to a trial but not included, such as
approval by an institutional ethical review board, because funding
bodies strictly enforce ethical review and medical journals usually
address reporting ethical review in their instructions for authors.
Other items may seem desirable, such as reporting on whether onsite monitoring was done, but a lack of empirical evidence or any
consensus on their value cautions against inclusion at this point.
The CONSORT 2010 Statement thus addresses the minimum
criteria, although that should not deter authors from including
other information if they consider it important.
After the meeting, the CONSORT Executive convened teleconferences and meetings to revise the checklist. After seven major
iterations, a revised checklist was distributed to the larger group for
feedback. With that feedback, the executive met twice in person to
consider all the comments and to produce a penultimate version.
That served as the basis for writing the first draft of this paper,
which was then distributed to the group for feedback. After
consideration of their comments, the executive finalised the
statement.
The CONSORT Executive then drafted an updated explanation and elaboration manuscript, with assistance from other
members of the larger group. The substance of the 2007
CONSORT meeting provided the material for the update. The
updated explanation and elaboration manuscript was distributed
to the entire group for additions, deletions, and changes. That final
iterative process converged to the CONSORT 2010 Explanation
and Elaboration. [13]
Box 1. Noteworthy General Changes in
CONSORT 2010 Statement
N
N
N
Changes in CONSORT 2010
The revision process resulted in evolutionary, not revolutionary,
changes to the checklist (Table 1), and the flow diagram was not
modified except for one word (Figure 1). Moreover, because other
reporting guidelines augmenting the checklist refer to item
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We simplified and clarified the wording, such as in items
1, 8, 10, 13, 15, 16, 18, 19, and 21.
We improved consistency of style across the items by
removing the imperative verbs that were in the 2001
version.
We enhanced specificity of appraisal by breaking some
items into sub-items. Many journals expect authors to
complete a CONSORT checklist indicating where in the
manuscript the items have been addressed. Experience
with the checklist noted pragmatic difficulties when an
item comprised multiple elements. For example, item 4
addresses eligibility of participants and the settings and
locations of data collection. With the 2001 version, an
author could provide a page number for that item on
the checklist, but might have reported only eligibility in
the paper, for example, and not reported the settings
and locations. CONSORT 2010 relieves obfuscations and
forces authors to provide page numbers in the checklist
for both eligibility and settings.
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Box 2. Noteworthy Specific Changes in CONSORT 2010 Statement
N
N
N
N
N
N
N
N
N
N
N
Item 1b (title and abstract)—We added a sub-item on
providing a structured summary of trial design, methods,
results, and conclusions and referenced the CONSORT for
abstracts article [21].
Item 2b (introduction)—We added a new sub-item (formerly item 5 in CONSORT 2001) on ‘‘Specific objectives or
hypotheses’’.
Item 3a (trial design)—We added a new item including this
sub-item to clarify the basic trial design (such as parallel
group, crossover, cluster) and the allocation ratio.
Item 3b (trial design)—We added a new sub-item that
addresses any important changes to methods after trial
commencement, with a discussion of reasons.
Item 4 (participants)—Formerly item 3 in CONSORT 2001.
Item 5 (interventions)—Formerly item 4 in CONSORT 2001.
We encouraged greater specificity by stating that descriptions of interventions should include ‘‘sufficient details to
allow replication’’ [3].
Item 6 (outcomes)—We added a sub-item on identifying any
changes to the primary and secondary outcome (endpoint)
measures after the trial started. This followed from empirical
evidence that authors frequently provide analyses of
outcomes in their published papers that were not the
prespecified primary and secondary outcomes in their
protocols, while ignoring their prespecified outcomes (that
is, selective outcome reporting). [4,22] We eliminated text on
any methods used to enhance the quality of measurements.
Item 9 (allocation concealment mechanism)—We reworded
this to include mechanism in both the report topic and the
descriptor to reinforce that authors should report the
actual steps taken to ensure allocation concealment rather
than simply report imprecise, perhaps banal, assurances of
concealment.
Item 11 (blinding)—We added the specification of how
blinding was done and, if relevant, a description of the
similarity of interventions and procedures. We also
eliminated text on ‘‘how the success of blinding (masking)
was assessed’’ because of a lack of empirical evidence
supporting the practice as well as theoretical concerns
about the validity of any such assessment [23,24].
Item 12a (statistical methods)—We added that statistical
methods should also be provided for analysis of secondary
outcomes.
N
N
N
N
N
N
N
N
N
that potential drawback and refer, for example, to trial protocols, to
information on trial registers, and to regulatory agency websites.
Moreover, the CONSORT 2010 Statement does not include
recommendations for designing and conducting randomised trials.
The items should elicit clear pronouncements of how and what the
authors did, but do not contain any judgments on how and what the
authors should have done. Thus, CONSORT 2010 is not intended
as an instrument to evaluate the quality of a trial. Nor is it
appropriate to use the checklist to construct a ‘‘quality score.’’
Nevertheless, we suggest that researchers begin trials with their
end publication in mind. Poor reporting allows authors, intentionally or inadvertently, to escape scrutiny of any weak aspects of their
trials. However, with wide adoption of CONSORT by journals and
editorial groups, most authors should have to report transparently
all important aspects of their trial. The ensuing scrutiny rewards well
conducted trials and penalises poorly conducted trials. Thus,
investigators should understand the CONSORT 2010 reporting
With CONSORT 2010, we again intentionally declined to
produce a rigid structure for the reporting of randomised trials.
Indeed, SORT [19] tried a rigid format, and it failed in a pilot run
with an editor and authors. [20] Consequently, the format of
articles should abide by journal style, editorial directions, the
traditions of the research field addressed, and, where possible,
author preferences. We do not wish to standardise the structure of
reporting. Authors should simply address checklist items somewhere in the article, with ample detail and lucidity. That stated, we
think that manuscripts benefit from frequent subheadings within
the major sections, especially the methods and results sections.
CONSORT urges completeness, clarity, and transparency of
reporting, which simply reflects the actual trial design and conduct.
However, as a potential drawback, a reporting guideline might
encourage some authors to report fictitiously the information
suggested by the guidance rather than what was actually done.
Authors, peer reviewers, and editors should vigilantly guard against
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Sub-item 14b (recruitment)—Based on empirical research,
we added a sub-item on ‘‘Why the trial ended or was
stopped’’ [25].
Item 15 (baseline data)—We specified ‘‘A table’’ to clarify
that baseline and clinical characteristics of each group are
most clearly expressed in a table.
Item 16 (numbers analysed)—We replaced mention of
‘‘intention to treat’’ analysis, a widely misused term, by a
more explicit request for information about retaining
participants in their original assigned groups [26].
Sub-item 17b (outcomes and estimation)—For appropriate
clinical interpretability, prevailing experience suggested
the addition of ‘‘For binary outcomes, presentation of both
relative and absolute effect sizes is recommended’’ [27].
Item 19 (harms)—We included a reference to the CONSORT
paper on harms [28].
Item 20 (limitations)—We changed the topic from ‘‘Interpretation’’ and supplanted the prior text with a sentence
focusing on the reporting of sources of potential bias and
imprecision.
Item 22 (interpretation)—We changed the topic from
‘‘Overall evidence.’’ Indeed, we understand that authors
should be allowed leeway for interpretation under this
nebulous heading. However, the CONSORT Group expressed concerns that conclusions in papers frequently
misrepresented the actual analytical results and that harms
were ignored or marginalised. Therefore, we changed the
checklist item to include the concepts of results matching
interpretations and of benefits being balanced with harms.
Item 23 (registration)—We added a new item on trial
registration. Empirical evidence supports the need for trial
registration, and recent requirements by journal editors
have fostered compliance [29].
Item 24 (protocol)—We added a new item on availability of
the trial protocol. Empirical evidence suggests that authors
often ignore, in the conduct and reporting of their trial,
what they stated in the protocol. [4,22] Hence, availability
of the protocol can instigate adherence to the protocol
before publication and facilitate assessment of adherence
after publication.
Item 25 (funding)—We added a new item on funding.
Empirical evidence points toward funding source sometimes
being associated with estimated treatment effects [30].
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March 2010 | Volume 7 | Issue 3 | e1000251
guidelines before starting a trial as a further incentive to design and
conduct their trials according to rigorous standards.
CONSORT 2010 supplants the prior version published in
2001. Any support for the earlier version accumulated from
journals or editorial groups will automatically extend to this newer
version, unless specifically requested otherwise. Journals that do
not currently support CONSORT may do so by registering on the
CONSORT website. If a journal supports or endorses CONSORT 2010, it should cite one of the original versions of
CONSORT 2010, the CONSORT 2010 Explanation and
Elaboration, and the CONSORT website in their ‘‘Instructions
to authors.’’ We suggest that authors who wish to cite CONSORT
should cite this or another of the original journal versions of
CONSORT 2010 Statement, and, if appropriate, the CONSORT
2010 Explanation and Elaboration. [13]. All CONSORT material
can be accessed through the original publishing journals or the
CONSORT website. Groups or individuals who desire to translate
the CONSORT 2010 Statement into other languages should first
consult the CONSORT policy statement on the website.
We emphasise that CONSORT 2010 represents an evolving
guideline. It requires perpetual reappraisal and, if necessary,
modifications. In the future we will further revise the CONSORT
material considering comments, criticisms, experiences, and
accumulating new evidence. We invite readers to submit
recommendations via the CONSORT website.
Acknowledgments
Supporting Information
Author Contributions
Figure S1
ICMJE criteria for authorship read and met: KFS DGA DM. Wrote the
first draft of the paper: KFS. Contributed to the writing of the paper: KFS
DGA DM. KFS, DGA, and DM participated in meetings and regular
conference calls, planned the CONSORT 2007 meeting at Montebello,
developed the agenda, prepared background research, identified and
invited participants, contributed to the CONSORT meeting, drafted the
manuscript, and, after critical review by the CONSORT Group, finalized
the text of the manuscript. Members of the CONSORT Group attended
the meeting, except for those noted in the Acknowledgments, and provided
input on and review of the revised checklist and text of this article. Some
members also prepared background material.
The CONSORT Group contributors to CONSORT 2010: DG
Altman, Centre for Statistics in Medicine, University of Oxford; Virginia
Barbour, PLoS Medicine; Jesse A Berlin, Johnson & Johnson Pharmaceutical
Research and Development, USA; Isabelle Boutron, University Paris 7
Denis Diderot, Assistance Publique des Hôpitaux de Paris, INSERM,
France; PJ Devereaux, McMaster University, Canada; Kay Dickersin,
Johns Hopkins Bloomberg School of Public Health, USA; Diana Elbourne,
London School of Hygiene & Tropical Medicine; Susan Ellenberg,
University of Pennsylvania School of Medicine, USA; Val Gebski,
University of Sydney, Australia; Steven Goodman, Journal of the Society for
Clinical Trials, USA; Peter C Gøtzsche, Nordic Cochrane Centre,
Denmark; Trish Groves, BMJ; Steven Grunberg, American Society of
Clinical Oncology, USA; Brian Haynes, McMaster University, Canada;
Sally Hopewell, Centre for Statistics in Medicine, University of Oxford;
Astrid James, Lancet; Peter Juhn, Johnson & Johnson, USA; Philippa
Middleton, University of Adelaide, Australia; Don Minckler, University of
California Irvine, USA; D Moher, Ottawa Methods Centre, Clinical
Epidemiology Program, Ottawa Hospital Research Institute, Canada;
Victor M Montori, Knowledge and Encounter Research Unit, Mayo
Clinic College of Medicine, USA; Cynthia Mulrow, Annals of Internal
Medicine, USA; Stuart Pocock, London School of Hygiene & Tropical
Medicine; Drummond Rennie, JAMA, USA; David L Schriger, Annals of
Emergency Medicine, USA; KF Schulz, Family Health International, USA;
Iveta Simera, EQUATOR Network; Elizabeth Wager, Sideview.
Contributors to CONSORT 2010 who did not attend the
Montebello meeting: Mike Clarke, UK Cochrane Centre; Gordon
Guyatt, McMaster University, Canada.
Flow diagram of the progress through the phases of a
parallel randomised trial of two groups (downloadable template
document for researchers to re-use).
Found at: doi:10.1371/journal.pmed.1000251.s001 (0.03 MB
DOC)
Text S1 CONSORT 2010 checklist of information to include
when reporting a randomised trial (downloadable template
document for researchers to re-use).
Found at: doi:10.1371/journal.pmed.1000251.s002 (0.11 MB
DOC)
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